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Orphan Drug Shows Survival Advantage in Mesothelioma


Long-term follow-up on a second-line drug for mesothelioma confirms its potential for prolonging survival.

NGR-hTNF is a vascular targeting agent that appears to be able to seek out tumor cells and disrupt their blood vessel formation. It is currently the only drug in Phase III clinical trials specifically for mesothelioma patients whose disease has returned after chemotherapy. Presenting at the recent meeting of the American Society of Clinical Oncology (ASCO), the drug’s maker, Italy-based MolMed S.p.A., said three year follow-up on Phase II mesothelioma trial subjects demonstrated a definite survival advantage among those who received the drug.

Because it combines a peptide (NGR) with a cytokine (TNF), the NGR-hTNF is classified as a peptide/cytokine complex.  In Phase II clinical trials, its effectiveness was evaluated both alone and in combination to treat recurrent malignant pleural mesothelioma. Follow-up on 57 of the Phase II mesothelioma patients showed those who received NGR-hTNF once a week instead of once every three weeks survived longer.

The Phase III trial, aimed at assessing the survival duration of 390 mesothelioma patients, is now in progress.  So far, 200 patients have been enrolled. Researchers told the ASCO attendees that the Phase II follow-up results “confirm the validity of the design of the pivotal Phase III study, currently the only ongoing in mesothelioma in 2nd line…”

A type of soft tissue sarcoma, malignant pleural mesothelioma develops in the tissues that surround the lungs, known as the pleura.  It is caused by exposure to asbestos.  The mineral fibers can migrate into the pleura when inhaled, creating DNA damage and setting up an inflammatory response that can eventually lead to cancer.  About 2,500 people in the U.S. are diagnosed with mesothelioma every year, a disease which is notoriously difficult to diagnose and treat.

NGR-hTNF has also been tested for liver, colorectal, small-cell lung and ovarian cancers. It holds orphan drug status in both the U.S. and the European Union for mesothelioma and liver cancer.


“MolMed: New Phase II Data on Investigational Drug NGR-h-TNF Presented at ASCO”, June 4, 2012, Press Release, MarketWatch.

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